NDC 55648-784

carbidopa, levodopa and entacapone

Carbidopa, Levodopa And Entacapone

carbidopa, levodopa and entacapone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Carbidopa; Entacapone; Levodopa.

Product ID55648-784_9866a9f3-77fb-43ec-b516-2a4dac01e1cc
NDC55648-784
Product TypeHuman Prescription Drug
Proprietary Namecarbidopa, levodopa and entacapone
Generic NameCarbidopa, Levodopa And Entacapone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-02-29
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021485
Labeler NameWockhardt Limited
Substance NameCARBIDOPA; ENTACAPONE; LEVODOPA
Active Ingredient Strength25 mg/1; mg/1; mg/1
Pharm ClassesAromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 55648-784-03

500 TABLET, FILM COATED in 1 BOTTLE (55648-784-03)
Marketing Start Date2012-02-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-784-01 [55648078401]

carbidopa, levodopa and entacapone TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021485
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29
Marketing End Date2012-05-30

NDC 55648-784-03 [55648078403]

carbidopa, levodopa and entacapone TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021485
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29
Inactivation Date2020-01-31

NDC 55648-784-02 [55648078402]

carbidopa, levodopa and entacapone TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021485
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-02-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CARBIDOPA25 mg/1

OpenFDA Data

SPL SET ID:dabb7f5d-03b3-4d46-951a-e41a1f8d69cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 730988
  • 810083
  • 403850
  • 403851
  • 403852
  • 810090
    • UPC Code
  • 0364679785027
  • 0364679783023
  • 0364679782026
  • 0364679787021

    • Pharmacological Class

    • Aromatic Amino Acid Decarboxylation Inhibitor [EPC]
    • DOPA Decarboxylase Inhibitors [MoA]
    • Catechol O-Methyltransferase Inhibitors [MoA]
    • Catechol-O-Methyltransferase Inhibitor [EPC]
    • Aromatic Amino Acid [EPC]
    • Amino Acids
    • Aromatic [CS]

    NDC Crossover Matching brand name "carbidopa, levodopa and entacapone" or generic name "Carbidopa, Levodopa And Entacapone"

    NDCBrand NameGeneric Name
    0378-8300Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    0378-8301Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    0378-8302Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    0378-8303Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    0378-8304Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    0378-8305Carbidopa, Levodopa and Entacaponecarbidopa, levodopa and entacapone
    16571-689CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    16571-690CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    16571-691CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    16571-692CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    16571-693CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    16571-694CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA, LEVODOPA AND ENTACAPONE
    47335-001Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    47335-002Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    47335-003Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    47335-004Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    47335-005Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    47335-006Carbidopa, levodopa and entacaponeCarbidopa, levodopa and entacapone
    55648-782carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    55648-783carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    55648-784carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    55648-785carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    55648-786carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    55648-787carbidopa, levodopa and entacaponecarbidopa, levodopa and entacapone
    64679-782CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
    64679-783CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
    64679-784CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
    64679-785CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
    64679-786CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
    64679-787CARBIDOPA, LEVODOPA AND ENTACAPONEcarbidopa, levodopa and entacapone
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